A Study of Sovilnesib in Subjects With Ovarian Cancer

NCT06084416
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
150
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Lead sponsor
Volastra Therapeutics, Inc.
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Start date
2024-04-04
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Number of sites
11
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Summary
This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.
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Short title
A Study of Sovilnesib in Subjects With Ovarian Cancer
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Official title
A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Selected Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2023-10-16
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Registry last updated
2026-10-13
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Primary completion date
2027-11-01
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Start date
2024-04-04
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Participants
150
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Participant count basis
Estimated
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Planned participants
150
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Protocol amendments
2
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Volastra Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06084416
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ClinicalTrials.gov ID
NCT06084416
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib

    Timeframe: Up to 24 months

  2. Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

    Timeframe: Up to 24 months

  3. Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

    Timeframe: Up to 24 months

  4. Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

    Timeframe: Up to 24 months

  5. Frequency of Dose Interruptions and Permanent Treatment Discontinuations

    Timeframe: Up to 24 months

  6. Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Timeframe: Up to 24 months

  1. Duration of Response (DOR) as assessed by RECIST version 1.1

    Timeframe: Up to 24 months

  2. Disease Control Rate (DCR) as assessed by RECIST version 1.1

    Timeframe: Up to 24 months

  3. Progression Free Survival (PFS) as assessed by RECIST version 1.1

    Timeframe: Up to 24 months

  4. Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria

    Timeframe: Up to 24 months

  5. Overall Survival (OS) (Part 2 only)

    Timeframe: Up to 24 months

  6. Plasma level of Sovilnesib

    Timeframe: Up to 24 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
  • Histologically confirmed locally advanced, inoperable, or metastatic tumor.
  • High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically confirmed; locally advanced, inoperable or metastatic; p16 positive (Part 2 only); platinum resistant (defined as radiographic progression/recurrence <180 days after last dose of ≥ 4 cycles of platinum containing therapy) or refractory; prior bevacizumab treatment, unless ineligible or intolerant; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor (unless ineligible or intolerant).

Key Exclusion Criteria:

  • Part 1 only: MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
  • Endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor or mixed tumors containing any of the above histologies
  • Previously received KIF18A inhibitor
  • Leptomeningeal disease, or new or progressive CNS metastases or spinal cord compression
  • Cardiac parameters: MI, PE, CABG, severe/unstable angina or stroke ≤ 6 months, NYHA Class ≥ II, LVEF < 50%
  • Any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug
Sources for eligibility
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  • The University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • University of Arkansas for Medical SciencesLittle Rock, United StatesActive, not recruiting
  • Hoag Memorial HospitalNewport Beach, United StatesActive, not recruiting
  • Georgia Cancer Center Augusta UniversityAtlanta, United StatesRecruiting
  • Johns Hopkins HospitalBaltimore, United StatesActive, not recruiting
  • Dana Farber Cancer InstituteBoston, United StatesActive, not recruiting
  • Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting
  • Icahn School of Medicine at Mount SinaiNew York, United StatesActive, not recruiting
  • OU Health Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • MUSC Hollings Cancer CenterCharleston, United StatesActive, not recruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesActive, not recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)